IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

[Golfman25]

Great inputs Sebastian.

Just wanted to chime in and say this is not as difficult as it sounds. Make yourself a quick table of you Control Methods today. Then simply determine what the "alternate" method would be if you were w/o that primary method.

i.e. - Note, there are only random examples off the top of my head to illustrate a point.
Primary method for 'inspection of defects': MIK - microscope
Alternate method: Manual visual inspection


Primary method of control of product dimensions: Caliper
Alternate method: Ruler

Primary method of controlling product output: SPC - statistical process control
Alternate method: FDC - fault detection classification

Ok, but what if you only had manual visual inspection capabilities and a ruler?

 

[malasuerte]

Ok, but what if you only had manual visual inspection capabilities and a ruler?

Then you need to devise an alternate control method.

In your 'scenario', you could have a template - the piece could 'fit into the template' or the template can be used as comparison.

You have to meet the requirement, but also do what works for your business.

 

[John C. Abnet]

Good day @bkirch;
Consider this...
What are the author's concerns? (i.e. why did they add this?)
Example:
ACME corporation uses a DC runner and controller to install threaded nuts on an assembly. During the manufacturing process, the DC runner breaks and they need to make shipment. What do they do ? They send "Tom" to the nearest hardware store to purchase a torque wrench.
Problem?
There are no established process controls, instructions, verification requirements, etc... necessary for the temporary process.

The key words here are "...Process Control..." What do organizations ALREADY have in place that defines process controls? The Control Plan.
Suggestion:
Simply add columns to the control plan template to allow for temporary process controls to be identified, including the need for the required additional verifications and frequencies.
Benefits:
This prevents the need for additional and fragmented documentation, when feasible gains customer pre-approval for if/when the temporary control is needed, and ensures sustainability (i.e. the control plan remains active for the life of the product).
Hope this helps.
Be well.

 

[Golfman25]

Then you need to devise an alternate control method.

In your 'scenario', you could have a template - the piece could 'fit into the template' or the template can be used as comparison.

You have to meet the requirement, but also do what works for your business.

That's kind of silly. We primarily use calipers and micrometers. If one fails, we grab another. No alternate needed.

 

[Johnson]

In fact, IATF 16949 Clause 8.5.6.1.1 requirements was originated from customer specific requiremnts, in this case, from GM BIQS-5 "Bypass / Deviation Management".
Due to this reason, there is a lots of confusion and mis-understanding about the requirements. So IATF has made revisons and SI's on this clause.

The follwoing is quoted from GM BIQS-5, which will help to understand IATF temporary process (equivelent to GM bypass management):

The plant shall identify manufacturing processes and error proofing devices which can be bypassed or placed in deviation. Risk Priority Number (RPN) for all approved Bypass / deviation processes are evaluated and risks are reviewed. Standard work instructions are available for each Bypass / deviation process.

Implemented bypasses/deviations are reviewed in daily Leadership Meeting with the goal to reduce or eliminate bypassed/deviated operations. Processes/devices in bypass / deviation must have a quality focused audits performed. Supplier locations that have a process in bypass/deviation shall have the bypass/deviation process checked on the daily LPA. Restart verification is documented for defined period. It should be 100% checked for all features


The following also came from GM for finding evidence if BIQS-5 is implemented.
Look for the plant list of manufacturing processes and error proofing devices which can be bypassed or placed in deviation. Confirm that Risk Priority Number (RPN) for all approved bypass / deviation processes are evaluated and that Standardized Work is available for each bypass/deviation process. Supplier locations shall have a written and approved bypass/deviation procedure that includes customer notification.

Ensure implemented bypasses/deviations are reviewed in Fast Response with the goal to reduce or eliminate bypassed/deviated operations. Look for evidence of the bypass / deviation checklist being used for processes/devices in bypass.